Abstract
Purpose: :
Several immunochromatography (IC) kits are available for rapid diagnosis of adenoviral conjunctivitis in clinics and in bedsides in Japan. We have developed a new IC kit (POCTEM®S Adeno) and evaluated it for the diagnosis for adenoviral conjunctivitis. We also compared its sensitivity and specificity to the other two pre-approved kits available in Japan.
Methods: :
The study sample consisted of 517 swabs from patients clinically diagnosed with adenoviral conjunctivitis from January, 2008 to October, 2010. These swab samples were collected from six collaborated ophthalmologic institutions with patients’ informed consent. Collected samples were tested with POCTEM®S Adeno and the other two pre-approved kits;Capilia® Adeno and Adeno Check®. The extracted viral DNA copies were further analyzed by real time polymerase chain reaction (RT-PCR) and sequenced for adnovirus (Ad) types. The sensitivity and specificity of POCTEM®S Adeno and the concordance rate to the other two available diagnostic kits were evaluated.
Results: :
In 136 adenoviral DNA-positive samples by PCR, POCTEM®S Adeno showed positive with DNA-copies ranging from 1x102 ~ 1x105 /μl. False negative was detected by POCTEM®S Adeno with DNA-copies ranging from 1x101 ~1x103 /μl. Sequence analysis on Ad type revealed Ad37(49%), Ad8(28%), Ad3(14%). POCTEM®S Adeno showed a concordance rate of 92% to RT-PCR and >90% concordance rate to the other two diagnostic kits.
Conclusions: :
POCTEM®S Adeno shows a concordance rate of >90% to the pre-approved adenovirus diagnosis kits. POCTEM®S Adeno could be another alternative for detection of Ad antigen for early diagnosis in clinics and bedsides.
Keywords: adenovirus • clinical (human) or epidemiologic studies: systems/equipment/techniques • conjunctivitis